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Johnson & Johnson and it’s Ethicon subsidiary face yet another product liability lawsuit over hernia mesh products sold in recent years, alleging that the Ethicon Proceed Ventral Patch poses an unreasonable risk of harm for individuals undergoing hernia repair.
The complaint (PDF) was filed earlier this month by James Williams in New Jersey Superior Court, indicating that the Ethicon Proceed hernia patch was defectively designed and sold without adequate warnings about the risk of complications that may result from use of the nine-layer mesh.
Williams indicates that his surgeons used an Ethicon Proceed Ventral Patch during a hernia repair surgery in July 2014, which was marketed by the manufacturers as safe and effective. However, the lawsuit indicates that the hernia patch failed within a few years, and had to be removed through a revision surgery in April 2016.
“The Proceed ventral Patch created an unreasonable risk of harm to Plaintiff James Williams,” according to the complaint. “The unreasonable risk of pain, dense adhesion formation, bowel complications, mesh shrinkage, hernia recurrence, seroma and fistula formation, and infection whether from prolonged and pronounced inflammatory response caused by the nine layers, degradation of polymers due to exposure to gamma radiation, non-conforming subcomponents, or some other mechanism renders the Ethicon Proceed a defective product.”
Williams indicates that due to complications from the Ethicon Proceed patch, he continues to suffer severe pain, nausea, diarrhea, chills, inflammation and other health problems due to complications from the hernia patch’s failure. It also indicates that he is now at such a high risk of further complications, that additional surgeries to fix the complications may not be feasible.
The lawsuit indicates that Ethicon and Johnson & Johnson knew that the oxidized regenerated cellulose layer used in the Proceed Ventral Patch was ineffective at preventing the formation of adhesions to the bowels before 2003, when the previous version, the Proceed Surgical Mesh, was introduced to the market. However, the lawsuit indicates that the manufacturer ignored warning signs of potential problems.
“Defendants failed to warn that the Ethicon Proceed creates a solid barrier preventing the body from adequately clearing or transporting fluid, which results in seroma formation, potentiating infections and fistula formation,” the lawsuit states. “Defendants never performed any clinical trials and/or studies before marketing the Ethicon Proceed. Defendants did not fully and/or adequately test the configuration of its new, nine-layer hernia mesh patch with OCR, polypropylene, Vicryl, and six layers of PDS, that was implanted in Plaintiff James Williams.”
The case joins a growing number of Ethicon Proceed lawsuits, as well as thousands of pending Ethicon Physiomesh lawsuits, which have been filed over problems with another multi-layer polypropylene hernia patch sold by the companies in recent years.
Ethicon Physiomesh was a newer hernia mesh design, which was introduced in 2010, featuring a similar multi-layered polypropylene design. However, it was quickly linked to a large number of reported complications among individuals who had the hernia patch placed in their body. As a result, Ethicon recalled the hernia patch in May 2016, removing the product from the market worldwide.